RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.

Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Secondary

Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.

Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).

OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.

Arm I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.

Arm II: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer

Newly diagnosed disease

Stage I-III disease

No diagnosed lymphedema

Must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of six sleeve sizes (i.e., all three measurments must be found in one column) available

Scheduled to undergo axillary node dissection with ≥ 10 nodes removed

No sentinel axillary node dissection only

Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female

Menopausal status not specified

No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly increases mortality over the next 2 years

May not be currently homebound or dependent upon a walker or wheelchair for mobility

Able to participate in a mild exercise program

No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer

Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis

Patients with basal cell and squamous cell carcinoma of the skin are eligible

May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection

Patients enrolled on ACOSOG-Z1071 allowed

Any type of radiotherapy to the breast or axilla allowed

Neoadjuvant treatment for this cancer allowed

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597